Irreversible Acute PulpitisNCT07241650
Evaluation of the Effects of Different Irrigation Solutions and Activation Methods on Postoperative Pain and Quality of Life in Root Canal Treatment
A study testing Irrigation with Sodium Hypochlorite and Conventional Syringe, Irrigation with Sodium Hypochlorite and EDDY and Procedure: Irrigation with Sodium Hypochlorite and Diode Laser in people with Irreversible Acute Pulpitis and Root Canal Treatment, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary: This prospective randomized controlled clinical trial aims to evaluate the effects of different irrigation solutions (NaOCl, HEDP) and activation methods (conventional syringe irrigation, EDDY, diode laser) on postoperative pain and oral health-related quality of life in single-visit root canal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irreversible Acute Pulpitis, Root Canal Treatment
- What is being tested?
- Irrigation with Sodium Hypochlorite and Conventional Syringe, Irrigation with Sodium Hypochlorite and EDDY and Procedure: Irrigation with Sodium Hypochlorite and Diode Laser
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemic Inclusion Criteria1. Volunteers must not have any systemic symptoms or be pregnant.2. According to the ASA classification, individuals with: • ASA I (Healthy (without acute and/or chronic diseases)• ASA II (with mild systemic diseases) (asymptomatic congenital heart disease, well-controlled dysrhythmias, non-exacerbated asthma, well-controlled epilepsy, non-insulin-dependent diabetes mellitus, oncological conditions in remission) will be included in our study.3. Must be between 18 and 65 years of age.4. Must not have used analgesic anti-inflammatory drugs in the last two weeks or cortisone in the last 6 months.5. Volunteers must be able to contact us again 6, 12, 24, 48, or 72 hours after completing their treatment and must be mentally fit enough to express pain scores and answer the questionnaire.6. Volunteers must not have bruxism.Local inclusion criteria 1. Mandibular molars must be present.2. Teeth must be asymptomatic preoperatively.There must be no palpation, percussion, or radiographic findings.3. Rubber dams must be attached to the teeth to be treated.4. The teeth must be in its normal position within the mouth.5. The volunteer must be able to open their mouth sufficiently.
Who cannot join
- 1. Volunteers who have used analgesics, anti-inflammatory drugs, antibiotics, etc. that could alter pain and infection control in the last 12 hours.2. Subjects with a history of sensitivity or adverse reactions to any medication or material used in this study3. Teeth with calcified canals or severe periodontal disease4. Subjects with missing opposing or adjacent teeth5. Pregnant or breastfeeding female subjects6. Teeth requiring additional anesthesia methods (e.g., intrapulpal, intraligamentary, second block anesthesia, or additional local anesthetic agent) will be excluded from the study if anesthesia is insufficient.7. Teeth with apical lesions will not be included in the study.8. Teeth with root resorption will not be included in the study.9. Teeth requiring restorations such as endocrowns, onlays, overlays, or full crowns due to excessive material loss after root canal treatment will not be included in the study.Teeth with structural loss sufficient to require post-core application will be excluded.10. Teeth with untreated periodontitis and teeth or sites that have undergone surgical treatment within the last 6 months will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain and Quality of Life in Root Canal Treatment: Prospective Study
Brief Summary: This prospective randomized controlled clinical trial aims to evaluate the effects of different irrigation solutions (NaOCl, HEDP) and activation methods (conventional syringe irrigation, EDDY, diode laser) on postoperative pain and oral health-related quality of life in single-visit root canal treatment of asymptomatic mandibular molars.
Read the detailed description
The primary aim of this prospective randomized controlled clinical trial is to evaluate the effects of two different irrigation solutions (2.5% NaOCl and HEDP) and three different activation methods (conventional syringe, EDDY, diode laser) on postoperative pain and oral health-related quality of life in single-visit root canal treatment of asymptomatic mandibular molars, aiming to overcome the limitations of conventional irrigation. Additionally, the study will compare patients' oral health-related quality of life before treatment and one week after treatment. While no significant difference in postoperative pain is expected, an improvement in quality of life is anticipated.Eligible participants will be adult patients requiring endodontic treatment of asymptomatic mandibular molars. After meeting inclusion criteria and providing informed consent, participants will be randomly assigned to six different groups. Randomization will be performed using a computer-generated random number sequence and the codes will be kept in sealed opaque envelopes to prevent bias between groups.The irrigation protocols and activation methods to be applied in the study are as follows:Irrigation Solutions: 2.5% NaOCl and HEDP (HEDP; Dual Rinse, Medcem GmbH, Weinfelden,Switzerland)Activation Techniques: Conventional syringe, EDDY (Micron, Tokyo, Japonya), diode laser Dentsply Sirona Sirolaser Advance; Sirona Dental Systems, Bensheim, Germany)Anesthesia: Regional mandibular block using Articaine-containing MaxicainAll procedures will be performed under rubber dam isolation. Root canal working length will be determined using a #10 K-type file and apex locator, and canals will be shaped using a nickel-titanium rotary system. Each canal will be irrigated according to the assigned protocol, and root canals will be obturated using gutta-percha and an epoxy resin-based sealer with a single-cone technique. Postoperative radiographs will be taken to confirm obturation, and definitive restorations will be completed with composite resin materials.Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 6, 12, 24, 36, 48, 72 hours, and one week after treatment. Quality of life will be measured using the OHIP-14 questionnaire before treatment and one week postoperatively.The study sample size is 90 participants, with 15 volunteers per group. All treatments will be performed by a single operator, and the materials and devices used in the study are standard products routinely used in clinical practice. The expected benefit of the study is to determine the effects of different irrigation solutions and activation methods on postoperative pain and patient quality of life, providing insights for clinical practice.
- Conditions
- Irreversible Acute Pulpitis, Root Canal Treatment
- Being tested
- Irrigation with Sodium Hypochlorite and Conventional Syringe, Irrigation with Sodium Hypochlorite and EDDY, Procedure: Irrigation with Sodium Hypochlorite and Diode Laser, Procedure: Irrigation with Etidronic Acid and Conventional Syringe, Procedure: Irrigation with Etidronic Acid and EDDY
- Keywords
- root canal irrigation, irrigation activation systems, EDDY, laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation with Sodium Hypochlorite and Conventional SyringeProcedure or surgery
Also called NaOCl activated with Conventional Syringe
Procedure: Irrigation with Sodium Hypochlorite and Conventional SyringeIn the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite delivered manually using a standard needle without any additional activation technique. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life.
Irrigation with Sodium Hypochlorite and EDDYProcedure or surgery
Also called NaOCl activated with EDDY
Procedure: Irrigation with Sodium Hypochlorite and EDDYSodium hypochloride with EDDY Activation In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite, which will be activated with EDDY for 10 seconds. Each canal will receive three cycles of 10-second EDDY activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life.
Procedure: Irrigation with Sodium Hypochlorite and Diode LaserProcedure or surgery
Also called NaOCl activated with Diode Laser
Procedure: Irrigation with Sodium Hypochlorite and Diode LaserSodium Hypochloride with Diode Laser Activation In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite, which will be activated with a diode laser for 10 seconds. Each canal will receive three cycles of 10-second laser activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life.
Procedure: Irrigation with Etidronic Acid and Conventional SyringeProcedure or surgery
Also called HEDP with Conventional Syringe
Procedure: Irrigation with Etidronic Acid and Conventional SyringeEtidronic Acid with Conventional Syringe In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite mixed with HEDP, delivered manually using a standard needle without additional activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life.
Procedure: Irrigation with Etidronic Acid and EDDYProcedure or surgery
Also called HEDP with EDDY
Etidronic Acid with EDDY Activation In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite mixed with HEDP, which will be activated with EDDY for 10 seconds. Each canal will receive three cycles of 10-second EDDY activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life.
Irrigation with Etidronic Acid and Diode LaserProcedure or surgery
Also called HEDP with diode laser
Etidronic Acid with Diode Laser Activation In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite mixed with HEDP, which will be activated with a diode laser for 10 seconds. Each canal will receive three cycles of 10-second laser activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Hypochlorite and Conventional Syringe | Experimental | Each canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite delivered manually using a conventional syringe, without any additional activation technique. Receives: Procedure: Irrigation with Sodium Hypochlorite and Conventional Syringe |
| Sodium Hypochlorite and EDDY | Experimental | Each canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite activated for 30 seconds using the EDDY sonic device. Receives: Procedure: Irrigation with Sodium Hypochlorite and EDDY |
| Sodium Hypochlorite and Diode Laser | Experimental | Each canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite activated for 30 seconds using a diode laser. Receives: Procedure: Procedure: Irrigation with Sodium Hypochlorite and Diode Laser |
| Etidronic Acid (HEDP) and Conventional Syringe | Experimental | Each canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of HEDP (Dual Rinse) solution delivered manually using a conventional syringe, without any additional activation technique Receives: Procedure: Procedure: Irrigation with Etidronic Acid and Conventional Syringe |
| Etidronic Acid (HEDP) and EDDY | Experimental | Each canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of HEDP (Dual Rinse) solution activated for 30 seconds using the EDDY sonic device. Receives: Procedure: Procedure: Irrigation with Etidronic Acid and EDDY |
| Etidronic Acid (HEDP) and Diode Laser | Experimental | Each canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of HEDP (Dual Rinse) solution activated for 30 seconds using a diode laser. Receives: Procedure: Irrigation with Etidronic Acid and Diode Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS scala
VAS (Visual Analog Scale): As its name suggests, the visual analog scale (VAS) uses an analog format, representing a continuous range of values. The most common way to measure pain on a VAS is with a 10 cm (100 mm) horizontal line. The volunteer is asked to place a mark on this line, which is then measured and recorded in millimeters or centimeters.According to the VAS scale, they will mark the pain they feel before treatment and after 6, 12, 24, 36, 48, 72 hours and 1 week (VAS) on the form.
Measured: 6., 12.,24.,36.,48.,72 hours and 1 week
OHIP test
(OHIP14) Scale will be asked to be filled before treatment and one week after treatment.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Nov 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Irreversible Acute PulpitisStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selen Yusufoğlu, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241650
- Sponsor's protocol ID
- 2025-13-19
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peters OA, Schonenberger K, Laib A. Effects of four Ni-Ti preparation techniques on root canal geometry assessed by micro computed tomography. Int Endod J. 2001 Apr;34(3):221-30. doi: 10.1046/j.1365-2591.2001.00373.x.
PubMed 12193268Scrimshaw SV, Maher C. Responsiveness of visual analogue and McGill pain scale measures. J Manipulative Physiol Ther. 2001 Oct;24(8):501-4. doi: 10.1067/mmt.2001.118208.
PubMed 11677548Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
PubMed 9332805Layton G, Wu WI, Selvaganapathy PR, Friedman S, Kishen A. Fluid Dynamics and Biofilm Removal Generated by Syringe-delivered and 2 Ultrasonic-assisted Irrigation Methods: A Novel Experimental Approach. J Endod. 2015 Jun;41(6):884-9. doi: 10.1016/j.joen.2015.01.027. Epub 2015 Mar 6.
PubMed 25749254Tungsawat P, Arunrukthavorn P, Phuntusuntorn P, Opatragoon S, Sirirangsee P, Inklub S. Comparison of the Effect of Three Irrigation Techniques and Root Canal Preparation Size on Sodium Hypochlorite Penetration into Root Canal Dentinal Tubules. Int J Dent. 2021 Mar 31;2021:6612588. doi: 10.1155/2021/6612588. eCollection 2021.
PubMed 33859692Cimpean SI, Pop-Ciutrila IS, Matei SR, Colosi IA, Costache C, Nicula GZ, Badea IC, Colceriu Burtea L. Effectiveness of Different Final Irrigation Procedures on Enterococcus faecalis Infected Root Canals: An In Vitro Evaluation. Materials (Basel). 2022 Sep 27;15(19):6688. doi: 10.3390/ma15196688.
PubMed 36234029Fortea L, Sanz-Serrano D, Luz LB, Bardini G, Mercade M. Update on chelating agents in endodontic treatment: A systematic review. J Clin Exp Dent. 2024 Apr 1;16(4):e516-e538. doi: 10.4317/jced.60989. eCollection 2024 Apr.
PubMed 38725809Castagnola R, Martini C, Colangeli M, Pellicciotta I, Marigo L, Grande NM, Bugli F, Plotino G. In Vitro Evaluation of Smear Layer and Debris Removal and Antimicrobial Activity of Different Irrigating Solutions. Eur Endod J. 2024 Jan 1;9(1):81-88. doi: 10.14744/eej.2023.19042. Epub 2023 Nov 15.
PubMed 37965676Allen PF. Assessment of oral health related quality of life. Health Qual Life Outcomes. 2003 Sep 8;1:40. doi: 10.1186/1477-7525-1-40.
PubMed 14514355
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain and Quality of Life in Root Canal Treatment: Prospective Study
- ClinicalTrials.gov ID
- NCT07241650
- Acronym / sponsor ID
- 2025-13-19
- Conditions
- Irreversible Acute Pulpitis, Root Canal Treatment
- Keywords
- root canal irrigation, irrigation activation systems, EDDY, laser
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief Summary: This prospective randomized controlled clinical trial aims to evaluate the effects of different irrigation solutions (NaOCl, HEDP) and activation methods (conventional syringe irrigation, EDDY, diode laser) on postoperative pain and oral health-related quality of life in single-visit root canal treatment of asymptomatic mandibular molars.
Detailed description
The primary aim of this prospective randomized controlled clinical trial is to evaluate the effects of two different irrigation solutions (2.5% NaOCl and HEDP) and three different activation methods (conventional syringe, EDDY, diode laser) on postoperative pain and oral health-related quality of life in single-visit root canal treatment of asymptomatic mandibular molars, aiming to overcome the limitations of conventional irrigation. Additionally, the study will compare patients' oral health-related quality of life before treatment and one week after treatment. While no significant difference in postoperative pain is expected, an improvement in quality of life is anticipated.Eligible participants will be adult patients requiring endodontic treatment of asymptomatic mandibular molars. After meeting inclusion criteria and providing informed consent, participants will be randomly assigned to six different groups. Randomization will be performed using a computer-generated random number sequence and the codes will be kept in sealed opaque envelopes to prevent bias between groups.The irrigation protocols and activation methods to be applied in the study are as follows:Irrigation Solutions: 2.5% NaOCl and HEDP (HEDP; Dual Rinse, Medcem GmbH, Weinfelden,Switzerland)Activation Techniques: Conventional syringe, EDDY (Micron, Tokyo, Japonya), diode laser Dentsply Sirona Sirolaser Advance; Sirona Dental Systems, Bensheim, Germany)Anesthesia: Regional mandibular block using Articaine-containing MaxicainAll procedures will be performed under rubber dam isolation. Root canal working length will be determined using a #10 K-type file and apex locator, and canals will be shaped using a nickel-titanium rotary system. Each canal will be irrigated according to the assigned protocol, and root canals will be obturated using gutta-percha and an epoxy resin-based sealer with a single-cone technique. Postoperative radiographs will be taken to confirm obturation, and definitive restorations will be completed with composite resin materials.Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 6, 12, 24, 36, 48, 72 hours, and one week after treatment. Quality of life will be measured using the OHIP-14 questionnaire before treatment and one week postoperatively.The study sample size is 90 participants, with 15 volunteers per group. All treatments will be performed by a single operator, and the materials and devices used in the study are standard products routinely used in clinical practice. The expected benefit of the study is to determine the effects of different irrigation solutions and activation methods on postoperative pain and patient quality of life, providing insights for clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sodium Hypochlorite and Conventional Syringe | Experimental | Procedure: Irrigation with Sodium Hypochlorite and Conventional SyringeEach canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite delivered manually using a conventional syringe, without any additional activation technique. |
| Sodium Hypochlorite and EDDY | Experimental | Procedure: Irrigation with Sodium Hypochlorite and EDDYEach canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite activated for 30 seconds using the EDDY sonic device. |
| Sodium Hypochlorite and Diode Laser | Experimental | Procedure: Procedure: Irrigation with Sodium Hypochlorite and Diode LaserEach canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite activated for 30 seconds using a diode laser. |
| Etidronic Acid (HEDP) and Conventional Syringe | Experimental | Procedure: Procedure: Irrigation with Etidronic Acid and Conventional SyringeEach canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of HEDP (Dual Rinse) solution delivered manually using a conventional syringe, without any additional activation technique |
| Etidronic Acid (HEDP) and EDDY | Experimental | Procedure: Procedure: Irrigation with Etidronic Acid and EDDYEach canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of HEDP (Dual Rinse) solution activated for 30 seconds using the EDDY sonic device. |
| Etidronic Acid (HEDP) and Diode Laser | Experimental | Procedure: Irrigation with Etidronic Acid and Diode LaserEach canal will be irrigated with 5 ml of saline for 30 seconds, followed by 10 ml of HEDP (Dual Rinse) solution activated for 30 seconds using a diode laser. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Systemic Inclusion Criteria1. Volunteers must not have any systemic symptoms or be pregnant.2. According to the ASA classification, individuals with: • ASA I (Healthy (without acute and/or chronic diseases)• ASA II (with mild systemic diseases) (asymptomatic congenital heart disease, well-controlled dysrhythmias, non-exacerbated asthma, well-controlled epilepsy, non-insulin-dependent diabetes mellitus, oncological conditions in remission) will be included in our study.3. Must be between 18 and 65 years of age.4. Must not have used analgesic anti-inflammatory drugs in the last two weeks or cortisone in the last 6 months.5. Volunteers must be able to contact us again 6, 12, 24, 48, or 72 hours after completing their treatment and must be mentally fit enough to express pain scores and answer the questionnaire.6. Volunteers must not have bruxism.Local inclusion criteria 1. Mandibular molars must be present.2. Teeth must be asymptomatic preoperatively.There must be no palpation, percussion, or radiographic findings.3. Rubber dams must be attached to the teeth to be treated.4. The teeth must be in its normal position within the mouth.5. The volunteer must be able to open their mouth sufficiently.
Key exclusion criteria (1 listed)
- 1. Volunteers who have used analgesics, anti-inflammatory drugs, antibiotics, etc. that could alter pain and infection control in the last 12 hours.2. Subjects with a history of sensitivity or adverse reactions to any medication or material used in this study3. Teeth with calcified canals or severe periodontal disease4. Subjects with missing opposing or adjacent teeth5. Pregnant or breastfeeding female subjects6. Teeth requiring additional anesthesia methods (e.g., intrapulpal, intraligamentary, second block anesthesia, or additional local anesthetic agent) will be excluded from the study if anesthesia is insufficient.7. Teeth with apical lesions will not be included in the study.8. Teeth with root resorption will not be included in the study.9. Teeth requiring restorations such as endocrowns, onlays, overlays, or full crowns due to excessive material loss after root canal treatment will not be included in the study.Teeth with structural loss sufficient to require post-core application will be excluded.10. Teeth with untreated periodontitis and teeth or sites that have undergone surgical treatment within the last 6 months will not be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrigation with Sodium Hypochlorite and Conventional SyringeAlso: NaOCl activated with Conventional SyringeProcedure: Irrigation with Sodium Hypochlorite and Conventional SyringeIn the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite delivered manually using a standard needle without any additional activation technique. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life. | Procedure or surgery | Sodium Hypochlorite and Conventional Syringe |
| Irrigation with Sodium Hypochlorite and EDDYAlso: NaOCl activated with EDDYProcedure: Irrigation with Sodium Hypochlorite and EDDYSodium hypochloride with EDDY Activation In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite, which will be activated with EDDY for 10 seconds. Each canal will receive three cycles of 10-second EDDY activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life. | Procedure or surgery | Sodium Hypochlorite and EDDY |
| Procedure: Irrigation with Sodium Hypochlorite and Diode LaserAlso: NaOCl activated with Diode LaserProcedure: Irrigation with Sodium Hypochlorite and Diode LaserSodium Hypochloride with Diode Laser Activation In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite, which will be activated with a diode laser for 10 seconds. Each canal will receive three cycles of 10-second laser activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life. | Procedure or surgery | Sodium Hypochlorite and Diode Laser |
| Procedure: Irrigation with Etidronic Acid and Conventional SyringeAlso: HEDP with Conventional SyringeProcedure: Irrigation with Etidronic Acid and Conventional SyringeEtidronic Acid with Conventional Syringe In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite mixed with HEDP, delivered manually using a standard needle without additional activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life. | Procedure or surgery | Etidronic Acid (HEDP) and Conventional Syringe |
| Procedure: Irrigation with Etidronic Acid and EDDYAlso: HEDP with EDDYEtidronic Acid with EDDY Activation In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite mixed with HEDP, which will be activated with EDDY for 10 seconds. Each canal will receive three cycles of 10-second EDDY activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life. | Procedure or surgery | Etidronic Acid (HEDP) and EDDY |
| Irrigation with Etidronic Acid and Diode LaserAlso: HEDP with diode laserEtidronic Acid with Diode Laser Activation In the final irrigation protocol, 5 ml of saline solution will be applied for 30 seconds, followed by 10 ml of 2.5% sodium hypochlorite mixed with HEDP, which will be activated with a diode laser for 10 seconds. Each canal will receive three cycles of 10-second laser activation. Participants will be instructed to record their postoperative pain using the Visual Analogue Scale (VAS) before treatment and at 6, 12, 24, 36, 48, and 72 hours, as well as 1 week after treatment. Additionally, they will complete the Oral Health Impact Profile questionnaire (OHIP-14) to assess the impact on quality of life. | Procedure or surgery | Etidronic Acid (HEDP) and Diode Laser |
Primary outcome
VAS scala
Time frame: 6., 12.,24.,36.,48.,72 hours and 1 week
VAS (Visual Analog Scale): As its name suggests, the visual analog scale (VAS) uses an analog format, representing a continuous range of values. The most common way to measure pain on a VAS is with a 10 cm (100 mm) horizontal line. The volunteer is asked to place a mark on this line, which is then measured and recorded in millimeters or centimeters.According to the VAS scale, they will mark the pain they feel before treatment and after 6, 12, 24, 36, 48, 72 hours and 1 week (VAS) on the form.
OHIP test
Time frame: 7 days
(OHIP14) Scale will be asked to be filled before treatment and one week after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 12193268Peters OA, Schonenberger K, Laib A. Effects of four Ni-Ti preparation techniques on root canal geometry assessed by micro computed tomography. Int Endod J. 2001 Apr;34(3):221-30. doi: 10.1046/j.1365-2591.2001.00373.x.
- Background: PubMed 11677548Scrimshaw SV, Maher C. Responsiveness of visual analogue and McGill pain scale measures. J Manipulative Physiol Ther. 2001 Oct;24(8):501-4. doi: 10.1067/mmt.2001.118208.
- Background: PubMed 9332805Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
- Background: PubMed 25749254Layton G, Wu WI, Selvaganapathy PR, Friedman S, Kishen A. Fluid Dynamics and Biofilm Removal Generated by Syringe-delivered and 2 Ultrasonic-assisted Irrigation Methods: A Novel Experimental Approach. J Endod. 2015 Jun;41(6):884-9. doi: 10.1016/j.joen.2015.01.027. Epub 2015 Mar 6.
- Background: PubMed 33859692Tungsawat P, Arunrukthavorn P, Phuntusuntorn P, Opatragoon S, Sirirangsee P, Inklub S. Comparison of the Effect of Three Irrigation Techniques and Root Canal Preparation Size on Sodium Hypochlorite Penetration into Root Canal Dentinal Tubules. Int J Dent. 2021 Mar 31;2021:6612588. doi: 10.1155/2021/6612588. eCollection 2021.
- Background: PubMed 36234029Cimpean SI, Pop-Ciutrila IS, Matei SR, Colosi IA, Costache C, Nicula GZ, Badea IC, Colceriu Burtea L. Effectiveness of Different Final Irrigation Procedures on Enterococcus faecalis Infected Root Canals: An In Vitro Evaluation. Materials (Basel). 2022 Sep 27;15(19):6688. doi: 10.3390/ma15196688.
- Background: PubMed 38725809Fortea L, Sanz-Serrano D, Luz LB, Bardini G, Mercade M. Update on chelating agents in endodontic treatment: A systematic review. J Clin Exp Dent. 2024 Apr 1;16(4):e516-e538. doi: 10.4317/jced.60989. eCollection 2024 Apr.
- Background: PubMed 37965676Castagnola R, Martini C, Colangeli M, Pellicciotta I, Marigo L, Grande NM, Bugli F, Plotino G. In Vitro Evaluation of Smear Layer and Debris Removal and Antimicrobial Activity of Different Irrigating Solutions. Eur Endod J. 2024 Jan 1;9(1):81-88. doi: 10.14744/eej.2023.19042. Epub 2023 Nov 15.
- Background: PubMed 14514355Allen PF. Assessment of oral health related quality of life. Health Qual Life Outcomes. 2003 Sep 8;1:40. doi: 10.1186/1477-7525-1-40.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation with Sodium Hypochlorite and Conventional Syringe, Irrigation with Sodium Hypochlorite and EDDY and Procedure: Irrigation with Sodium Hypochlorite and Diode Laser in people with Irreversible Acute Pulpitis and Root Canal Treatment, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS scala (time frame: 6., 12.,24.,36.,48.,72 hours and 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07241650, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.